The Stratagem team keeps evolving and the start of 2018 sees some changes. Joe Costello in our IP support team is leaving to become a BT engineer and is replaced by the highly experienced and CIPA qualified  Lauren Palmer. In April we are joined by another experienced trade mark attorney Emma Hewson to expand our very busy team. 

We also say goodbye to Kevin Hanson who is leaving to join a local law firm; Amritjot Jethwa is increasing her hours and will now be our lead solicitor. We are also about to expand our IT team as so much of what we do relies on the tech working!.

After such a turn in the weather we are nowlooking forward to Spring!

Changes to the regulation of medical devices in Europe

If your business innovates/manufactures, distributes or sells medical devices in Europe, or plans to do so, you will need to be aware of the latest legal changes made on 25 May 2017. (Click here)

These two new Regulations harmonise the law on marketing of medical devices in the majority of Europe and will hopefully improve quality/safety of those medical devices as well as the transparency/quality of information provided to consumers.

Key changes include:

Classification – the scope of both Regulations is significantly increased compared to the Directives, including the definition of devices covered:

A medical device now includes: “any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specified medical purposes….”; and

An in-vitro diagnostic medical device now includes: “a reagent, a reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body…”

You may need to check if you are affected: some “devices” having no intended medical use, e.g. software/cosmetic fillers/non-corrective lenses/3D printed items are now regulated, while others warrant increased obligation, as they have been up-classified.

Clinical data – reduced equivalence reliance, increased data on high risk classes, publishing of safety data, post market follow up.  Existing devices will NOT automatically be granted a certificate.

Pre-market activity – increased scrutiny for high risk classes, common specs and new responsible person/other requirements throughout supply chain.

Post-market activity – new central database (EUDAMED), Clinical Evaluation Reporting (CER) frequency increase - updated at least annually for high risk or new devices and every 2 to 5 years otherwise.

Traceability – Unique Device Identification (UDI) for tagging and tracking for every product.

Compliance Periods

The new MDR is fully applicable on 26 May 2020; with a transitional period of 3 years (starting last year - 25 May 2017), whereas the new IVDR is fully applicable on 26 May 2022 giving a longer transitional period of 5 years. Until these dates in 2020 and 2022, CE certificates under the old directives remain valid.

During the transitional period devices can still be placed on the market under the old Directives; MDD/AIMDD/IVDD certificates issued within the transitional period are valid but limited in duration of up to 2 (IVDD) or 4 years (MDD/AIMDD) maximum after the date of application.

After the transitional period any business involved in the supply chain of a medical device must meet the full requirements of the relevant new Regulation (e.g. via an extended period of conditional CE certificate validity referred to above, or a new certificate). Significant change in design or use will require new certification.
 
Further assistance

In view of these deadlines, a business that forms part of the medical device supply chain will likely require internal preparation.

The MHRA has an excellent timeline (Click here)  and explanation of the compliance needed in the supply chain by party type (Click here)

We also recommend (British Standards Institution, a Notified Body) as a resource for further detail on regulatory-specific issues, including practical task lists and planning checks, which are available for free (Click here)

This significant legal change may also impact your contractual liability/obligations regarding your products and IP; please contact Stratagem if you have concern in that regard.

Working Statements in India

For granted patents in India, a yearly statement needs to be filed at the Indian Patent Office, outlining the extent to which the invention has been worked on a commercial scale in India.

If a patent is not worked, then reasonable explanations for this need to be provided, e.g. that options for commercialisation are under consideration or that the likely demand for the product is being explored. For pharmaceutical products, pending regulatory approval or ongoing clinical testing could also be a factor contributing to non-working. Patents which remain unworked in India for more than 3 years can become subject to compulsory licensing from the Indian Patent Office, and/or revocation.

If the patent is being worked (this includes products protected by the patent being exported to India), then the statement must indicate quantum and value of the product. If there are any licenses for the patent granted to Indian companies, then this would also classify as being “worked” and a list of the licenses is required to be submitted.

As examination of Indian patent applications tend to be very delayed in comparison with patent family members elsewhere, many patentees are not in a position to be obliged to inform the Indian patent office of working the invention until several years after filing, giving more scope for commercialisation to have occurred.  

The Stratagem team will work with you to ensure that the response filed is appropriate and timely, to avoid the possible serious consequences of non-compliance with these rules, including financial penalties and even criminal prosecution in cases where the response filed is fraudulent. 

The requirement to file Working Statements in India is a peculiarity to the Indian Patents Act (1970) which becomes due by 31st of March every year. It can be difficult for the applicant or licensee to comply with the requirement to disclose potentially sensitive or confidential information, and there are particular challenges associated with patents in sectors such as information and technology.  Your usual Stratagem attorney can discuss particular aspects of your case with you if there are any difficulties. 

We are looking forward to making contact with all our clients who hold granted patents in India over the coming weeks, and to advising on complying with the working requirements appropriately. If you are not a current Stratagem client, then please do not hesitate to contact us to discuss how we may assist you in this and other IP management matters.

Brexit and Patents – it’s business as usual.

While many aspects of UK and European law will be affected by the UK’s withdrawal from the EU, patent work will continue unchanged.

Fortunately, the European Patent system is not an EU system and is, therefore, unaffected by Brexit. The grant of European Patents is governed by an international treaty (known as the European Patent Convention) and will therefore be unaffected when the UK leaves the EU. Patentees will still be able to obtain patent protection for the UK through the European Patent Office (EPO), in exactly the same way as they do today. Stratagem will continue to be able to file, prosecute, validate and oppose European Patents for clients before the EPO covering all the EPC countries as is the current practice.  There will be also be no change to UK national patents or PCT applications (PCT).

Stratagem will continue to represent UK and overseas clients before the European Patent Office in exactly the same way as we do now.
If you have any questions or concerns about IP Rights post- Brexit, or would like further advice on this matter, please contact your usual Stratagem Attorney.